Design and methodology of the NorthStar Study: NT-proBNP stratified follow-up in outpatient heart failure clinics -- a randomized Danish multicenter study.
BACKGROUND
Randomized clinical trials have shown that newly discharged and symptomatic patients with chronic heart failure (CHF) benefit from follow-up in a specialized heart failure clinic (HFC). Clinical stable and educated patients are usually discharged from the HFC when on optimal therapy. It is unknown if risk stratification using natriuretic peptides could identify patients who would benefit from longer-term follow-up. Furthermore, data on the use of natriuretic peptides for monitoring of stable patients with CHF are sparse.


OBJECTIVE
The aims of this study are to test the hypothesis that clinical stable, educated, and medical optimized patients with CHF with N-terminal pro-brain natriuretic peptide (NT-proBNP) levels > or = 1,000 pg/mL benefit from long-term follow-up in an HFC and to assess the efficacy of NT-proBNP monitoring.


METHODS
A total of 1,250 clinically stable, medically optimized, and educated patients with CHF will be enrolled from 18 HFCs in Denmark. The patients will be randomized to treatment in general practice, to a standard follow-up program in the HFC, or to NT-proBNP monitoring in the HFC. The patients will be followed for 30 months (median).


RESULTS
Data will be collected from 2006 to 2009. At present (March 2008), 720 patients are randomized. Results expect to be presented in the second half of 2010.


CONCLUSIONS
This article outlines the design of the NorthStar study. If our hypotheses are confirmed, the results will help cardiologists and nurses in HFCs to identify patients who may benefit from long-term follow-up. Our results may also indicate whether patients with CHF will benefit from adding serial NT-proBNP measurements to usual clinical monitoring.
Schou
Morten
M
The Danish Heart Failure Clinics Network, C/O Frederiksberg University Hospital, Frederiksberg, Denmark. m.schou@dadlnet.dk
Gustafsson
Finn
F
Videbaek
Lars
L
Markenvard
John
J
Ulriksen
Hans
H
Ryde
Henrik
H
Jensen
Jens C H
JC
Nielsen
Tonny
T
Knudsen
Anne S
AS
Tuxen
Christian D
CD
Handberg
Jens
J
Sørensen
Per J
PJ
Espersen
Geert
G
Lind-Rasmussen
Søren
S
Keller
Niels
N
Egstrup
Kenneth
K
Nielsen
Olav W
OW
Abdulla
Jawdat
J
Nyvad
Ole
O
Toft
Jens
J
Hildebrandt
Per R
PR
D000553:Ambulatory Care / Q000379:methods*; D000554:Ambulatory Care Facilities; D003266:Continuity of Patient Care; D003718:Denmark; D006333:Heart Failure / Q000097:blood / Q000628:therapy*; D006801:Humans; D008991:Monitoring, Physiologic / Q000379:methods*; D015337:Multicenter Studies as Topic; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010446:Peptide Fragments / Q000097:blood; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain